Abstract

Background - Vaccination is the most effective method of preventing infectious diseases. The immunogenicity of a vaccine can be stimulated by an adjuvant. GPI-0100 adjuvant has shown great promise in mice studies. However, research of GPI-
0100 in humans is limited.
Objective - Here the safety aspect of the use of GPI-0100adjuvant from human studies is summarized.
Methods- The Pubmed and Embase databases were searched with the search terms: ‘GPI-0100’, ‘Clinical’ and ‘Adjuvant’. The criteria for reporting were studies that were done in humans.
Results – The most common local adverse events that were observed in the three studies were mild (grade I) to moderate (grade II) local reactions and mild (grade I) pain at the injection site. GPI-0100 administered at a dose of 3000 µg showed
comparable toxicity profile in the three studies. The dose of GPI-0100 appeared to be no cause in increasing numbers of local adverse events.
Conclusion- GPI-0100 is a promising adjuvant that shows little safety concerns and a low threshold of toxicity.